Kornimate/medical-research-clean huggingface dataset:
study of cabiralizumab in combination with nivolumab in patients with selected advanced cancers

Conditions: Advanced Solid Tumors; Head and Neck Cancer; Pancreatic Cancer; Ovarian Cancer; Renal Cell Carcinoma; Malignant Glioma; Non-small Cell Lung Cancer

Summary: phase 1a/1b does-escalation study of cabiralizumab alone and with nivolumab in advanced solid tumors.

this is a phase 1a/b single-arm, open-label study to evaluate safety, tolerability, pharmacokinetics (pk), and clinical benefit of cabiralizumab in combination with nivolumab in patients with selected advanced cancers.

Eligibility criteria:
inclusion criteria: * patients must have at least one measurable lesion at baseline by computed tomography (ct) or magnetic resonance imaging (mri) as per response evaluation criteria in solid tumors (recist) v1.1 criteria. * patients must have had progressive disease on, after, or refused, appropriate approved therapy for their tumor type. * patients must have histologically or cytologically confirmed solid tumor that is locally recurrent or metastatic and has progressed following standard treatment or is not appropriate for standard treatment * understand and sign an institutional review board/independent ethics committee (irb/iec)-approved informed consent form (icf) prior to any study-specific evaluation * eastern cooperative oncology group (ecog) performance status of 0 or 1 * willing and able to comply with all study procedures exclusion criteria: * current or history of clinically significant muscle disorders (e.g., myositis), recent unresolved muscle injury, or any condition known to elevate serum creatine kinase (ck) levels * decreased cardiac function with new york heart association (nyha) \> class 2 * uncontrolled or significant heart disorder such as unstable angina * significant abnormalities on electrocardiogram (ecg) at screening. fridericia's correction formula for qt interval (qtcf) \> 450 msec for males or \> 470 msec for females at screening * history of anti-drug antibodies, severe allergic, anaphylactic, or other infusion-related reaction to a previous biologic agent * positive test for latent tuberculosis (tb) at screening (quantiferon test) or evidence of active tb * patients with abnormal serum chemistry values, which in the opinion of the investigator is considered to be clinically significant, will be excluded from the study * lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples * any uncontrolled medical condition or psychiatric disorder which, in the opinion of the investigator, would pose a risk to patient safety or interfere with study participation or interpretation of individual patient results * pregnant or breastfeeding * current unresolved infection or history of chronic, active, clinically significant infection (viral, bacterial, fungal, or other) which, in the opinion of the investigator, would preclude the patient from exposure to a biologic agent or pose a risk to patient safety * prior exposure to any colony stimulating factor 1 receptor (csf1r) pathway inhibitors
a multi-site clinical evaluation of the aries clostridium difficile assay in symptomatic patients

Conditions: Gastroenteritis; Infectious Colitis

Summary: the aries c. difficile assay is a real-time pcr based qualitative in vitro diagnostic test for the direct detection of c. difficile nucleic acid in stool specimens.

the aries c. difficile assay is a real-time polymerase chain reaction (pcr) based qualitative in vitro diagnostic test for the direct detection of clostridium difficile (c. difficile) nucleic acid in unformed (liquid or soft) stool specimens obtained from patients suspected of having clostridium difficile associated disease (cdad). the objective of this study is to establish diagnostic accuracy of aries c. difficile assay through a multi-site, method comparison on prospectively collected, left-over, stool specimens. diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).

Eligibility criteria:
inclusion criteria: * the specimen is from a patient suspected of having c. difficile associated disease (cdad). * the subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted for testing at the site. exclusion criteria: * the specimen is preserved. * the specimen was not properly collected, transported, processed or stored according to the instructions provided by the sponsor.

Keywords: aries clostridium difficile
effect of lumbo-sacral magnetic stimulation on colonic motility

Conditions: Functional Colonic Disease; Fecal Incontinence

Summary: the purpose of this study is to evaluate the effect of sacral nerve magnetic stimulation on the colonic motility in healthy subjects, in incontinent and constipated patients.


Eligibility criteria:
inclusion criteria: healthy volunteers exclusion criteria: pregnant women metallic material implanted organic digestive disease neuro-surgery

Keywords: sacral magnetic stimulation fecal incontinence constipation
osteosarcoma study #2: a randomized trial of pre-surgical chemotherapy vs. immediate surgery and adjuvant chemotherapy in the treatment of non-metastatic osteosarcoma. a pediatric oncology group phase iii study

Conditions: Osteosarcoma

Summary: the study is designed to determine if the administration of multi-drug adjuvant chemotherapy for patients with primary non-metastatic osteogenic sarcoma, both prior to and after the definitive surgical procedure for their primary tumor is superior as a treatment strategy to the current approach of giving drugs only after the definitive surgical procedure has been performed. an effort will be made as well to determine if the administration of pre-definitive surgery, chemotherapy leads to an increase in the proportion of the patients suitable for a limb salvage primary surgical procedure.

the study is designed to determine if the administration of multi-drug adjuvant chemotherapy for patients with primary non-metastatic osteogenic sarcoma, both prior to and after the definitive surgical procedure for their primary tumor is superior as a treatment strategy to the current approach of giving drugs only after the definitive surgical procedure has been performed. an effort will be made as well to determine if the administration of pre-definitive surgery, chemotherapy leads to an increase in the proportion of the patients suitable for a limb salvage primary surgical procedure.

Eligibility criteria:
must be less than or equal to 30 years of age. no prior history of cancer. no prior therapy-other than biopsy. informed consent according or institutional guidelines (agreement to randomization to either presurgical chemotherapy or immediate surgery-physicians must also agree). less than or equal to 21 days since initial diagnosis and eligible to have surgery within 3 weeks of randomization. must have a high grade osteosarcoma. must not have low grade osteosarcoma, periosteal and parosteal osteosarcoma, or multi-focal sclerosing of osteosarcoma. tumor must be confined to extremity or expendable and resectable bone of axial skeleton (i.e., ilium, scapula, clavicle, rib). no evidence of metastases by pe, cxr, chest ct, and bone scans. (chest ct must be normal within 2 weeks of randomization). abnormalities on chest ct must be biopsy-negative or thoracotomy negative. suspicious lesions on bone scan should be biopsied. ldh level and surgical intent (i.e., amputation, resection, or limb replacement) must be known before patient is registered.

Keywords: non-metastatic osteosarcoma presurgical chemotherapy
different doses of intravenous administered dexamethasone effecting brachial plexus supraclavicular block

Conditions: End Stage Renal Failure

Summary: to compare the analgesic properties of ultrasound guided supraclavicular block using ropivacaine 0.5% in arteriovenous fistula creation when used in combination with intravenous administered dexamethasone at 4mg and 8 mg as an adjuvant


Eligibility criteria:
inclusion criteria: adult, age 18 to 65 years end stage renal disease patients for av fistula creation exclusion criteria: not suitable candidate as determined by the primary team refusal for brachial plexus block history of allergy to dexamethasone or local anesthesia pregnancy history of previous brachial plexus injury coagulopathy local skin site infection known neuropathy involving the arm undergoing surgery patients with glucose reading more then 12mmol/
a phase 1b study of [225ac]ac-aky-1189 in patients with solid tumors

Conditions: Urothelial Carcinoma Bladder; Triple Negative Breast Cancer (TNBC); Hormone Receptor Positive Breast Adenocarcinoma; Non Small Cell Lung Cancer; Cervical Adenocarcinoma; Colorectal Adenocarcinoma; Head and Neck Cancer

Summary: this is a first-in-human phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a nectin-4 radiopharmaceutical (\[225ac\]ac-aky-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (mtd) or maximum administered dose (mad) and the recommended part 2 dose.

this study consists for two parts (part 1 and 2). part 1 is the dose escalation portion of the study, which will investigate ascending doses of \[225ac\]ac-aky-1189 (up to 6 cycles) in patients with locally advanced or metastatic urothelial cancer. the aim of part 1 is to determine the maximum tolerated dose (mtd) or maximum administered dose (mad) and the recommended part 2 dose. part 2 will be the dose expansion portion of the study and will enroll locally advanced or metastatic solid tumor patients who are identified as nectin-4 positive by \[64cu\] cu-aky-1189. part 2 aims to further assess the efficacy on \[225ac\]ac-aky-1189 at the rp2d in 3 different cohorts of patients.

Eligibility criteria:
inclusion criteria: * histologic or cytologic confirmation of locally advance or metastatic disease * radiologic confirmation on ct of at least one measurable tumor lesion per recist v1.1 * ecog performance status of 0 or 1 * adequate end-organ function * ability to give informed consent and comply with study requirements * patients with cns metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids * documented disease progression on prior line of therapy for metastatic disease exclusion criteria: * prior treatment with a therapeutic radiopharmaceutial * received an investigational agent within the previous 28days * prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy in the 3 weeks prior to study treatment * concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity
investigation of transvenous versus epicardial left ventricular stimulation technique

Conditions: Heart Failure

Summary: the purpose of this study is to demonstrate that epicardial and transvenous left ventricular leads are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with a crt device.

this clinical trial is a multicenter, prospective, randomized, parallel, open study designed to compare epicardial left ventricular pacing to transvenous left ventricular pacing for delivering cardiac resynchronization therapy. after a pre-implant baseline evaluation, patients will be randomized in a 1:1 fashion to one of two groups: * control group: resynchronization via a transvenous left ventricular lead (tvn crt); * treatment group: resynchronization via an epicardial left ventricular lead (epi crt). all patients taking part in this study will undergo the implantation of a crt device with or without icd back-up (depending on the physician's decision), with right atrial and right ventricular transvenous leads. patients will attend protocol scheduled visits before implant (pre-implant baseline evaluation), and post-implant: before hospital discharge, 6 weeks post-implant (optional visit), 3 months (optional visit), and 6 months after implant, time of study termination.

Eligibility criteria:
inclusion criteria: * have an approved indication for implantation of an crt device (esc guidelines , including any update); * have a stable pharmacological therapy. exclusion criteria: * have a contra-indication to general anesthesia; * have a scheduled cardiac surgery; * have had a recent myocardial infarction, unstable angina or cardiac revascularization (ptca or cabg) within 1 month of enrollment; * have a life expectancy of less than 6 months; * are unable to provide informed consent; * are unable to comply with the follow-up schedule and tests; * are minor (age below 18 years); * are pregnant or are planning for pregnancy in the next 6 months.

Keywords: epicardial leads cardiac resynchronization therapy
gatekeeper for soiling and gas incontinence

Conditions: Gas Incontinence; Soilings, Fecal

Summary: faecal incontinence has a broad spectrum of symptoms. some patients only suffer commonly considered mild symptoms: gas incontinence and soiling, but patients' quality of life is significantly impaired. although several treatments for faecal incontinence are available, this subgroup of patients are difficult to treat, and no therapeutic alternative has been clearly defined. the aim of this study is to evaluate gatekeeper™ treatment for this subgroup of patients with faecal incontinence, not studied before. consecutive case series single-centre study. patients with mainly soiling and/or gas incontinence were treated with polyacrylonitrile prostheses


Eligibility criteria:
inclusion criteria: * patients older than 18 years old * with at least 6 months of gi and/or soiling * non-responding to conservative treatment and biofeedback. exclusion criteria: * complete solid and liquid fi * common bristol score \> 4 * malignant diseases * chronic diarrhoea * inflammatory bowel disease * acute anorectal disease * rectal prolapse * neurological disease, * obstructive defecation syndrome * low anterior resection syndrome, * previous pelvic radiation, * any anaesthetic contraindication * st. mark's score \> 12 * external anal sphincter lesion \> 30º.
assessment of insulin sensitivity in healthy adults by a 13c-glucose breath test : method development and validation

Conditions: Insulin Sensitivity/Resistance

Summary: the current research project aims to assess the insulin resistance (less sensitivity), from measures of insulin and glucose in response to a standard oral intake of glucose (standardized oral glucose tolerance test). for this, we wish to test and validate the method of glucose labelled 13-c (stable isotope) breath test in comparison with standardized methods to measure glucose and insulin. comparative methods that will be used are measures of glycemia from venous blood withdrawal and continuous glucose measurement in the skin tissue (external face of the arm) using the abbott's freestyle libre system. repeatability and reliability of the 13-c glucose breath test will be checked from repeated measures over time.

the current research project aims to assess the insulin resistance (less sensitivity), from measures of insulin and glucose in response to a standard oral intake of glucose (standardized oral glucose tolerance test). for this, we wish to test and validate the method of glucose labelled 13-c (stable isotope) breath test in comparison with standardized methods to measure glucose and insulin. comparative methods that will be used are measures of glycemia from venous blood withdrawal and continuous glucose measurement in the skin tissue (external face of the arm) using the abbott's freestyle libre system. repeatability and reliability of the 13-c glucose breath test will be checked from repeated measures over time.

Eligibility criteria:
inclusion criteria: healthy male adults aged 18-40 able to understand and to sign a written informed consent exclusion criteria: * exclusion criteria * known type 1 or type 2 diabetes, by anamnesis * family history of type 2 diabetes (parents) * history of gestational diabetes * any other metabolic disease possibly impacting the postprandial glucose and insulin response (anamnesis) * any medication impacting the energetic metabolism, to the opinion of the investigator * pregnant or lactating women (anamnesis) * smoking * allergy or intolerance to any food or compound used in this study * currently following a strict exercise program (more than three times per week) in order to either lose weight, gain muscle or reach competition standards for a chosen sport * having given blood in the past three months or willing to give blood in the 3 months following the completion of the study * currently participating or having participated in another clinical trial during the past month. * volunteer who cannot be expected to comply with the protocol
the connectedcancercare pilot study (ccc)

Conditions: Early-stage Breast Cancer; Breast Cancer Female; Survivorship; Cancer Survivors; Transitional Care

Summary: this study is an nci-funded, randomized control pilot trial to evaluate: (1) the feasibility and acceptability of a web-based, personalized navigation tool (connectedcancercare) and (2) explore whether the tool improves delivery of team-based survivorship care for women who have recently finished primary breast cancer treatment.

this study is a randomized control pilot trial involving 60 women newly diagnosed with early-stage breast cancer who are finishing primary treatment. participants will be randomized either to the intervention arm (ccc website that provides information on team-based follow-up care for both cancer surveillance and preventive care) or the control arm (static online survivorship care plan template, adapted from the asco breast cancer survivorship template). the feasibility and acceptability of the tool and correlations with patient-reported outcomes will be assessed 3 months following the completion of a baseline survey via an online follow-up survey.

Eligibility criteria:
inclusion criteria: * diagnosed with early stage (0-iib) breast cancer * must be a patient of a university of michigan breast cancer oncologist * must be completing primary cancer treatment and transitioning into survivorship * must be able to speak, read and write in english * must have access and the ability to use the internet exclusion criteria: * diagnosed with stage iii or iv breast cancer * unable to speak, read, and write in english

Keywords: breast cancer survivors survivorship plan transitional cancer care
effects of meditation on sleep quality of medical students

Conditions: Sleep Disorder

Summary: the objective of the study is to evaluate the effect of an 8-week online mindfulness-based meditation program on quality sleep status of undergraduate students medicine in the city of passo fundo/rs and chapecó/sc in addition to sleep quality, secondary outcomes such as mindfulness, symptoms of depression, stress, anxiety and burnout will also be assessed

a controlled, single-center, randomized parallel group clinical trial will be developed to evaluate the effectiveness of an online mindfulness-based meditation program (pombm) on the quality of sleep of medical students. the trial expects to involve 136 participants who will be randomized 1:1 into the intervention group or a waiting group (which will be called the control group), with 68 expected participants each. all trial procedures will take place online via google meet and will consist of an invitation and presentation of the study, followed by an initial screening visit for those interested, and an intervention period of 8 weeks. the pombm will be administered weekly online during the intervention period, with each session lasting 45 to 60 minutes. the control group will not perform any activities during the intervention period. participants in both groups will be evaluated at the initial visit (t0), in the fifth week (t1), immediately after the end of the intervention period (t2) and in a 2-month follow-up after the end of the program (t3) using the following instruments : psqi (pittsburgh quality sleep index), ese (epworth sleepiness scale), maas (mindful attention awareness scale), dass-21 (depression, anxiety and stress scale), and cbi-s (copenhagen burnout inventory student version)

Eligibility criteria:
inclusion criteria: * interest in participating in the study; over 18 years old; both genders; being duly registered in the medicine course at passo fundo or chapecó's faculties, from the 1st to 12th phase of the course exclusion criteria: * have participated in another course or workshop on meditation in the last 4 weeks in addition to the invitation to study; being an active practitioner of meditation, yoga, tai-chi, qui-gong (at least 6 months before the start of the study); previous medical diagnosis of cognitive, language or communication deficits; alcohol dependence and other chemical substances; previous medical diagnosis of a disorder with risk of suicide or attempt of previous suicide; previous medical diagnosis of post-traumatic stress disorder; previous medical diagnosis of depressive disorder currently untreated; previous medical diagnosis of schizophrenia or delusional/hallucinatory disorders; previous medical diagnosis of social anxiety (difficulty being in a classroom)

Keywords: sleep disorder
gamified app on increasing physical activity and reducing anxiety in autism

Conditions: Autism Spectrum Disorder; Physical Activity; Anxiety; Mobile Health

Summary: background: physical activity (pa) has an impact on physical and mental health in neurotypical populations, and addressing these variables may improve the prevalent burden of anxiety in adults with autism spectrum disorder (asd). gamified mobile apps using behavior change techniques present a promising way of increasing pa and reducing sedentary time, thus reducing anxiety in adults with asd. objective: this study aimed to compare the effectiveness of a gamified and behavior change technique-based mobile app, puzzlewalk, versus a commercially available app, google fit, on increasing pa and reducing sedentary time as an adjunct anxiety treatment for this population. methods: a total of 24 adults with asd were assigned to either the puzzlewalk or google fit group for 5 weeks using a covariate-adaptive randomization design. pa and anxiety were assessed over 7 days at 3 different data collection periods (ie, baseline, intervention start, and intervention end) using triaxial accelerometers and the beck anxiety inventory. group differences in outcome variables were assessed using repeated-measures analysis of covariance, adjusting for age, sex, and bmi.


Eligibility criteria:
inclusion criteria: * self-reported medical diagnosis of anxiety or self-identification of experiencing anxiety symptoms for the past 3 or more months * access to a supported device (smartphones with android 4.4 and higher or ios 9.0 and higher operating system) * cognitive ability to understand the purpose of the study * no prior experience using the pa mobile apps used in the study exclusion criteria: * individuals with low cognitive function, co-occurring intellectual disabilities, or mobility impairments